Lymphocyte changes and vaccination response in a child exposed to belimumab during pregnancy

Bitter, Helle; Bendvold, Anne Noraas; Østensen, Monika

doi:10.1136/annrheumdis-2018-213004

Cited by 24 publications

(18 citation statements)

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“…Apparently harmless reversible low infant total and B cell lymphocyte count without a significant rise in infection rates or abnormal vaccination course was reported after exposure to rituximab ( Azim et al, 2010 ; Chakravarty et al, 2011 ; Das et al, 2018 ). A similar effect was seen in one case report with belimumab exposure ( Bitter et al, 2018 ). These cellular effects were mostly transient and reverted to normal within months.…”

Section: Biologic Drug-induced Maternal and Infant Immunological Changessupporting

confidence: 85%

Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road

et al. 2021

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Females are generally more affected by autoimmune diseases, a fact that underlines the relationship with pregnancy and the safety of anti-rheumatic drugs in pregnancy and lactation. Biologic therapies are increasingly prescribed to treat and maintain remission in a significant number of systemic autoimmune rheumatic diseases. The experience with the use of biologics during gestation is extremely lacking because of the observational nature of the available studies and the difficulty in designing proper clinical trials in pregnancy. Among the studied biologics, more information was published on TNFα inhibitors and, in particular, on their potential passage through the placenta and impact on the fetus. Currently, a fragment of anti-TNFα monoclonal IgG, certolizumab pegol, is considered safe with almost no placental transfer. Subsequent observations are suggesting a comparable safety for the soluble TNFα receptor etanercept. Another biologic, eculizumab, the anti-C5a antibody used to treat complement-mediated microangiopathies, is also considered safe due to the unique engineered IgG2/4κ formulation that limits its passage through the placental barrier. Still, long-term data about children born to women treated with biologics in pregnancy are not attainable. Data on breastfeeding are currently available for several biologics. This article reviews the literature available about which drugs are considered safe during pregnancy and lactation, which are not, and on future prospects.

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Section: Biologic Drug-induced Maternal and Infant Immunological Changessupporting

confidence: 85%

Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road

et al. 2021

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“…B cells were in the normal range at 4 months of age. Rotavirus vaccination 6 weeks after birth and diphtheria-tetanus-pertussis, haemophilus, and pneumococcus vaccinations at 3 and 5 months of age resulted in satisfactory responses [143].…”

Section: Belimumabmentioning

confidence: 96%

Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review

Ghalandari

Dolhain

Hazes

et al. 2020

Drugs

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Background Inflammatory autoimmune diseases are chronic diseases that often affect women of childbearing age. Therefore, detailed knowledge of the safety profile of medications used for management of inflammatory autoimmune diseases during pregnancy is important. However, in many cases the potential harmful effects of medications (especially biologics) during pregnancy (and lactation) on mother and child have not been fully identified. Objective Our aim was to update the data on the occurrence of miscarriages and (major) congenital malformations when using biologics during pregnancy based on newly published articles. Additionally, we selected several different secondary outcomes that may be of interest for clinicians, especially information on adverse events in the use of a specific biologic during pregnancy. Material and Methods A search was conducted from 1 January 2015 until 4 July 2019 in Embase.com, Medline Ovid, Web of Science, Cochrane CENTRAL, and Google Scholar with specific search terms for each database. Selection of publications was based on title/abstract and followed by full text (double blinded, two researchers). An overview was made based on outcomes of interest. References of the included publications were reviewed to include and minimize the missing publications. Results A total of 143 publications were included. The total number of cases ranged from nine for canakinumab to 4276 for infliximab. The rates of miscarriages and major congenital malformations did not show relevant differences from those rates in the general population. Conclusion Despite limitations to our study, no major safety issues were reported and no trend could be identified in the reported malformations.

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“…82 B-cell depletion has been well documented in infants exposed to rituximab and belimumab. 50,51,83 Should patients taking biologics continue breastfeeding?…”

Section: Can a Patient Taking Biologics Receive Immunizations During Pregnancy?mentioning

confidence: 99%

“…Case series 65,82 and more recently, cohort studies 59,76,96 have described exposed infants who received this vaccine without serious complications, such as vaccine-associated rotavirus disease. 83,[97][98][99] Rotavirus infection from the live-attenuated vaccine has been limited primarily to patients with severe combined immune deficiency, [100][101][102] suggesting that this adverse event is mostly observed in children with severe T-and B-cell immunodeficiency and not with other immune defects or mild immunosuppression. [103][104][105] Specialist assessment of immune function is recommended before considering administration of rotavirus vaccination, with careful review of the specific drug exposure.…”

Section: Should Infants Exposed To Biologics Be Immunized?mentioning

confidence: 99%

The use and impact of monoclonal antibody biologics during pregnancy

Pham‐Huy

Top

Constantinescu

et al. 2021

CMAJ

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Increasingly, pregnant patients with inflammatory or autoimmune diseases use monoclonal antibody biologics before conception, during pregnancy and while breastfeeding. Anti-TNFα Infliximab Chimeric anti-TNFα IgG1 Rheumatoid arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis Adalimumab Recombinant humanized anti-TNFα IgG1 Rheumatoid arthritis, polyarticular JIA, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, uveitis Golimumab Humanized anti-TNFα IgG1 Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, ulcerative colitis Certolizumab pegol Recombinant, humanized antibody to the antigen-binding fragment to anti-TNFα Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis Etanercept Human recombinant TNFα receptor/IgG1-Fc fusion protein Ankylosing spondylitis, rheumatoid arthritis, polyarticular JIA, psoriatic arthritis, plaque psoriasis Anticytokine Ustekinumab Anti-IL-12 and IL-23 humanized IgG1 Plaque psoriasis, psoriatic arthritis, Crohn disease, ulcerative colitis Tocilizumab Anti-IL-6 receptor humanized IgG1 Rheumatoid arthritis, polyarticular and systemic JIA, giant cell arteritis Canakinumab Anti-IL-1β human IgG1 CAPS, TRAPS, HIDS, MKD, FMF, systemic JIA Anti-integrin Vedolizumab Humanized anti-α4β7 integrin IgG1 Ulcerative colitis, Crohn disease Natalizumab Anti-integrin α4 subunit humanized IgG4 Multiple sclerosis Anti-B cell Rituximab Anti-CD20 IgG1 Rheumatoid arthritis, non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis Belimumab Anti-B-cell activating factor human IgG1 Systemic lupus erythematosus Note: CAPS = cryopyrin-associated periodic syndromes, FMF = familial Mediterranean fever, HIDS = hyperimmunoglobulin D syndrome, Ig = immunoglobulin, IL = interleukin, JIA = juvenile idiopathic arthritis, MKD = mevalonate kinase deficiency, TNF = tumour necrosis factor, TRAPS = tumour necrosis factor receptor associated periodic syndrome. *Off-label use not listed. Box 1: Evidence used in this narrative reviewWe conducted a literature review of preclinical and clinical studies in PubMed, published from January 2005 to February 2021. We searched for articles relevant to the use of monoclonal antibody biologics during pregnancy using the following search terms: biologics, monoclonal antibody biologics, pregnancy, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, rituximab and neonatal outcomes. Given the rapid emergence of data pertaining to this topic, we also reviewed selected abstracts, published expert guidelines and case reports. In addition, we reviewed the bibliographies of articles from high-impact journals in the fields of gastroenterology, rheumatology and dermatology. Recently published articles were preferred to reflect the most upto-date evidence for this review.

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Lymphocyte changes and vaccination response in a child exposed to belimumab during pregnancy

Cited by 24 publications

References 1 publication

Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road

Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road

Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review

The use and impact of monoclonal antibody biologics during pregnancy

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